The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for Novartis Cosentyx (secukinumab) in polymyalgia rheumatica (PMR). The recommendation positions the drug as the first interleukin-17A (IL-17A) inhibitor licensed in Europe for this condition, targeting adults with inadequate response to steroids or relapse during steroid taper.

Clinical Trial Data

The opinion follows results from the pivotal REPLENISH Phase III trial, published in the New England Journal of Medicine and presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress. The global, randomized, double-blind study evaluated efficacy and safety across 27 countries.

Key findings from the trial include:

Patients were randomized into three arms: Cosentyx 300mg, Cosentyx 150mg, or placebo, all combined with a 24-week steroid taper regimen. Both active treatment arms met all primary and secondary endpoints, including complete sustained remission and time until additional treatment was needed through week 52.

What the Numbers Show

The data reveals a divergence between current standard-of-care limitations and the drug’s efficacy. While long-term steroid use—the existing standard—is associated with significant risks like osteoporosis and diabetes, Cosentyx delivered a steroid-sparing effect without introducing new safety signals. This suggests a potential shift in risk-benefit profiles for PMR patients, who currently face up to 40% relapse rates in the first year under conventional therapy.

Regulatory Pathway

Following the CHMP recommendation, the European Commission is expected to issue a final decision within approximately two months. If approved, Cosentyx will expand its portfolio beyond current indications in psoriatic arthritis, plaque psoriasis, ankylosing spondylosis, non-radiographic axial spondyloarthritis, and hidradenitis suppurativa.

Patrick Horber, M.D., President of International at Novartis, stated that the approval would represent an important step in transforming care for those living with PMR, building on the drug’s established impact in autoimmune disease.

Novartis India outlined a strategy to double its annualized run rate of ₹650 crore within four to five years, driven by recent acquisitions and a commercial reset. The company acquired the Minipress XL trademark from Pfizer and in-licensed ophthalmology brands to expand its portfolio.

Strategic Shift and Acquisitions

Management announced a shift from a flat revenue trajectory to a growth-focused model centered on six anchor therapy areas: cardiology, pain management, women's health, CNS, transplant, and ophthalmology. To support this, the company is building a direct sales force covering approximately 150,000 healthcare practitioners and expanding its distribution network from four cash-and-carry forwarders (C&Fs) to nearly 25.

The most significant recent move was the acquisition of the Minipress XL trademark from Pfizer Inc. Minipress XL holds over 50% market share in the alpha-blocker segment, with reported MAT July '26 revenue of ₹228 crore. The brand has grown at a CAGR of 6.5%, lagging the broader market growth of 9-10%. Management expects an initial EBITDA of roughly ₹90 crore from this asset against an investment of ₹1,250 crore, targeting a payback period of eight to nine years post-synergies.

Additionally, the company in-licensed the ophthalmology portfolio comprising Pagenax and Accentrix from NHPL for an upfront fee of ₹10 crore. This portfolio contributes over ₹100 crore in revenue, providing a platform for further expansion in eye care.

Financial Outlook and Costs

The transition involves significant near-term costs. Quarterly operating expenses are expected to rise from a legacy run rate of ₹10-15 crore to ₹40-50 crore as the company builds its team and marketing infrastructure. Management anticipates these costs will be fully reflected from Q4 onwards, with the sales engine operational by December. Consequently, short-term profitability may dip before recovering, with margins expected to return to above 20% within two to three years.

What the Numbers Show

The acquisition of Minipress XL highlights a strategic focus on high-return, established assets rather than greenfield development. With an implied entry multiple of roughly 14x EBITDA (₹1,250 crore investment vs ₹90 crore EBITDA), the return profile relies heavily on execution-driven margin expansion and volume growth exceeding the current 6.5% CAGR to meet the targeted eight-to-nine-year payback period.

Governance and Ownership

ChrysCapital holds a 70.68% stake in the company following an open offer priced at ₹860.64 per share. The new board includes independent directors with extensive industry experience, such as Ramesh (ex-MD 3M India), Suchita Sharma, and Shashank Sinha (ex-MD Strides Pharma). Management confirmed that trademarks for core brands like Voveran and Methergin have been assigned to the company, while Sandoz brands remain under long-term licensing agreements without future royalties.